(267 days)
The Pruitt F3-S Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
The Pruitt F3-S Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels, allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. The Pruitt F3-S Shunts are multi-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3-S Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon.
The provided document describes the LeMaitre Vascular Pruitt F3-S Carotid Shunt (K143454) and its substantial equivalence to a predicate device. This is a medical device submission, not a study of an AI algorithm, so many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or do not directly translate. However, I can extract information related to the device's performance testing and acceptance criteria as described in the summary.
Acceptance Criteria and Device Performance for Pruitt F3-S Carotid Shunt
The document focuses on demonstrating substantial equivalence to a predicate device (Pruitt F3 Carotid Shunt K051067) by comparing technological characteristics and performing functional/safety testing. It does not provide explicit numerical acceptance criteria values or specific performance results for each test in a table format, but rather states that the device "meets the product performance requirements of the device specifications."
However, based on the "Summary of Product Testing," we can infer the aspects of performance that were evaluated.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Inferred from "Meets product performance requirements of the device specifications") | Reported Device Performance |
|---|---|---|
| Shunt lumen diameter | Device demonstrates appropriate lumen diameter for its intended function of allowing blood flow between carotid arteries, as per design specifications. | "meets the product performance requirements of the device specifications" |
| Balloon diameter | Balloons inflate to the specified diameters to effectively stabilize the shunt within the common and internal carotid arteries, as per design specifications and IFU data. | "meets the product performance requirements of the device specifications" |
| Balloon deflation time | Balloons deflate within an acceptable timeframe to allow for proper removal or adjustment, as per design specifications. | "meets the product performance requirements of the device specifications" |
| Balloon radial force | Balloons exert sufficient radial force to anchor the shunt securely without causing undue trauma, as per design specifications. | "meets the product performance requirements of the device specifications" |
| Kink test | The shunt resists kinking under normal physiological and surgical usage conditions to maintain patency, as per design specifications. | "meets the product performance requirements of the device specifications" |
| Balloon inflation curve | The relationship between inflation volume and balloon diameter is consistent with specifications, guiding users for proper inflation. | "meets the product performance requirements of the device specifications" |
| Sterilization | Device is sterile as defined by ANSI/AAMI/ISO 11135-1:2007. | "is ethylene oxide (EO) sterilized according to ANSI/AAMI/ISO 11135-1:2007" |
| Biocompatibility | Materials are biocompatible and do not elicit adverse biological responses. | "The materials used... are identical to those in the predicate device which has established biocompatibility." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" for a statistical study in the way an AI algorithm might. The testing described is pre-clinical functional and safety testing on the device itself.
- Sample Size: Not explicitly stated for each test, but typically these tests involve a representative sample of devices.
- Data Provenance: The tests are performed by the manufacturer, LeMaitre Vascular, Inc., likely at their facilities in Burlington, MA, USA, as part of their internal verification process. The data is prospective, generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not directly applicable. The "ground truth" for a medical device's functional integrity is established by engineering specifications, recognized industry standards (like ISO 11135-1 for sterilization), and comparison to predicate devices, rather than expert consensus on a diagnostic outcome. The "experts" involved would be the engineers and quality assurance personnel at LeMaitre Vascular.
4. Adjudication Method for the Test Set
Not applicable. This type of testing relies on objective measurements against predefined engineering specifications, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., images) with and without AI assistance. The Pruitt F3-S Carotid Shunt is a physical medical device, not a diagnostic AI algorithm.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable, as this is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on engineering specifications, design requirements, and established performance characteristics of the predicate device. For biocompatibility, it's the known biocompatibility profile of the materials used in the predicate device. For sterilization, it's compliance with an international standard (ANSI/AAMI/ISO 11135-1:2007).
8. The Sample Size for the Training Set
Not applicable, as this is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI algorithm requiring a training set.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
LeMaitre Vascular, Inc Xiang Zhang Director of Regulatory Affairs 63 Second Avenue Burlington, Massachusetts 01803
Re: K143454 Trade/Device Name: Pruitt F3-S Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: July 20, 2015 Received: July 27, 2015
Dear Xiang Zhang,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143454
Device Name Pruitt F3-S Carotid Shunt
Indications for Use (Describe)
The Pruitt F3-S Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K143454
510k Summary
Submitter's Information
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue, Burlington, MA 01803 |
| Phone: | 781-425-1706 |
| Fax: | 781-425-5049 |
| Contact Person: | Xiang (Vic) ZhangGlobal Director of Regulatory AffairsLeMaitre Vascular, Inc.Email: xzhang@lemaitre.com |
| Date Prepared: | August 26, 2015 |
| Device Name: | Pruitt F3-S Carotid Shunt |
| Trade Name: | Pruitt F3-S Carotid Shunt |
| Common Name: | Catheter, intravascular occluding, temporary |
| Regulation Number: | 21CFR §870.4450 |
| Classification Panel: | Cardiovascular |
| Class: | II (2) |
| Product Code: | MJN |
| EstablishmentRegistration: | 1220948 |
| Establishment: | 63 Second AvenueBurlington, MA 01803 |
| Predicate Device: | Pruitt F3 Carotid Shunt K051067 |
| Reference Device: | Vascushunt Carotid Shunt K861790 |
| Device Description: | The Pruitt F3-S Carotid Shunt is designed to serve as anartificial passage connecting two blood vessels, allowingblood flow from one vessel to another. This isaccomplished by using a clear, plastic, sterile conduit thatis held in place by a stabilization technique (balloons) onboth ends of the conduit.The Pruitt F3-S Shunts are multi-lumen devices withballoons on both the distal (internal carotid) and proximal(common carotid) ends of the shunt. The balloons, wheninflated independently, act as a stabilization mechanism to |
| maintain the position of the shunt when it is placed withinthe common and internal carotid arteries. | |
| The Pruitt F3-S Carotid Shunt has features to aid the userduring shunt insertion and balloon inflation. The inflationpath of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock,through the blue lumen and into the blue common carotidballoon. | |
| Intended Use: | The Pruitt F3-S Carotid Shunt is indicated for use in carotidendarterectomy as a temporary conduit to allow for bloodflow between the common and internal carotid arteries. |
| Summary of TechnologicalCharacteristics: | Comparisons of the Pruitt F3-S Shunt with the predicatePruitt F3 Shunt show that technological characteristics suchas materials, biocompatibility, performance, sterilization,and packaging of the proposed device are substantiallyequivalent to the predicate device. The design modificationof the proposed device compared to that of the predicatedevice are:• Removal of the pressure relief balloon on theinternal inflation arm;• Provide balloon diameter vs. inflation volume datain the IFU to guide the users |
| Functional/Safety Testing: | The verification activities conducted indicate that Pruitt F3-S Carotid Shunt meets the product performancerequirements of the device specifications and does not raiseany additional safety issues. |
| Sterilization: | The device is ethylene oxide (EO) sterilized according toANSI/AAMI/ISO 11135-1:2007, "Sterilization of MedicalDevices - Validation and Routine Control of EthyleneOxide Sterilization" |
| Biocompatibility: | The materials used in Pruitt F3-S Carotid Shunt areidentical to those in the predicate device which hasestablished biocompatibility. |
| Summary of ProductTesting: | The following tests have been completed to evaluate thesafety and performance of the Pruitt F3-S Carotid Shunt:• Shunt lumen diameter• Balloon diameter• Balloon deflation time• Balloon radial force• Kink test• Balloon inflation curve |
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Summary of Pre-clinical N/A Study: Conclusion: LeMaitre Vascular has demonstrated that the Pruitt F3-S Carotid Shunt is substantially equivalent to the predicate devices based on its intended use and fundamental scientific technology.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).